Venous UlcersNCT02930499
Effect of Hyaluronic Acid ECM on Venous Ulcers
A study testing Hyalomatrix extra-cellular matrix and Mepilex wound dressing in people with Venous Ulcers, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial summary
The purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Venous Ulcers
- What is being tested?
- Hyalomatrix extra-cellular matrix and Mepilex wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18-85 years of age with chronic venous insufficiency (CVI) and the presence of venous ulceration for longer than 2 months
- Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages
- Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period.
Who cannot join
- Ulcers of non-venous etiology
- Subject has a known sensitivity to hyaluronic acid
- Presence of wound infection as determined by clinical signs and symptoms
- Subject has any evidence of peripheral arterial disease (PAD)
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
- Pregnancy or lactation at time of treatment.
Show all 10Show fewer
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
- History of alcohol or drug abuse.
- Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vascular and Wound Care Center, University Hospital
Newark, New Jersey, 07101
About this study
Official title: A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Hyaluronic Acid Extracellular Matrix (Hyalomatrix®) in the Management of Chronic Venous Ulcers
The purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. The study also intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.
- Conditions
- Venous Ulcers
- Being tested
- Hyalomatrix extra-cellular matrix, Mepilex wound dressing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalomatrix extra-cellular matrixDevice
An exta-cellular matrix made from hyaluronic acid
Mepilex wound dressingDevice
Also called non-adhesive foam wound dressing
A siliconized non-adhesive foam wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid ECM (Hyalomatrix) | Experimental | Hyalomatrix ECM will be applied to the target ulcer once weekly Receives: Device: Hyalomatrix extra-cellular matrix |
| Non-Adherent wound dressing (Mepilex) | Active comparator | Mepilex wound dressing will be applied to the target ulcer once weekly Receives: Device: Mepilex wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
Measured: 16 weeks
Secondary outcomes (1)
Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Investigator relocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
- Investigators
- Oscar M Alvarez, PhD, Principal investigator, Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930499
- Sponsor's protocol ID
- ML-HM-0115-VLU
- Status last verified
- Mar 2017
- First submitted
- 1 Sep 2016
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Hyaluronic Acid Extracellular Matrix (Hyalomatrix®) in the Management of Chronic Venous Ulcers
- ClinicalTrials.gov ID
- NCT02930499
- Acronym / sponsor ID
- ML-HM-0115-VLU
- Conditions
- Venous Ulcers
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Investigator relocation
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. The study also intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid ECM (Hyalomatrix) | Experimental | Device: Hyalomatrix extra-cellular matrixHyalomatrix ECM will be applied to the target ulcer once weekly |
| Non-Adherent wound dressing (Mepilex) | Active comparator | Device: Mepilex wound dressingMepilex wound dressing will be applied to the target ulcer once weekly |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients 18-85 years of age with chronic venous insufficiency (CVI) and the presence of venous ulceration for longer than 2 months
- Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages
- Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period.
Key exclusion criteria (10 listed)
- Ulcers of non-venous etiology
- Subject has a known sensitivity to hyaluronic acid
- Presence of wound infection as determined by clinical signs and symptoms
- Subject has any evidence of peripheral arterial disease (PAD)
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyalomatrix extra-cellular matrixAn exta-cellular matrix made from hyaluronic acid | Device | Hyaluronic Acid ECM (Hyalomatrix) |
| Mepilex wound dressingAlso: non-adhesive foam wound dressingA siliconized non-adhesive foam wound dressing | Device | Non-Adherent wound dressing (Mepilex) |
Primary outcome
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
Time frame: 16 weeks
1 secondary outcome
Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar M Alvarez, PhD principal investigator
Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalomatrix extra-cellular matrix and Mepilex wound dressing in people with Venous Ulcers, run by Calvary Hospital, Bronx, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Hyalomatrix® plus standard care on the incidence of wound healing (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.